Reduced-Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Malignant Hematological Diseases

NCT00582894 | Completed Results DMC

• 2 other identifiers: Reduced-IntensityIRB #11835
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate engraftment and toxicity of a reduced intensity preparative regimen for patients who receive a matched related or unrelated donor allogeneic stem cell transplant (ASCT) for malignant hematological diseases

Conditions

Hematological Neoplasms; Hematopoietic Stem Cell Transplantation

Keywords

Allogenic stem cell transplant; Hematologic diseases

Outcome Measures

Primary Outcomes (2)

• Number of Participants Experiencing Transplant Related Mortality (TRM)

  At Day 100 post trans-plant

• Number of Participants Experiencing Engraftment Donor Chimerism (EDC)

  At time of study termination

Secondary Outcomes (2)

• Number of Participants Relapse-Free

  100 days post-transplant

• Number of Participants Overall Survival as a Function of Time.

  100 days post transplant

Study Arms (1)

A

OTHER

Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1

Drug: Busulfex, Fludarabine, ALemtuzumab

Interventions

Busulfex, Fludarabine, ALemtuzumab DRUG

Busulfex 3.2 mg/kg/day for 2 days infused over 3 hours, Days -6 and Day-5 Fludarabine 30 mg/m2/day for 5 days on Day -6 to D-2 Alemtuzumab 10 mg/day IV on Days -5 to -1

A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Performance status 0-2
• Ejection fraction \> 30%
• AST/ALT and bilirubin not \> 4 times normal
• Creatinine clearance greater than 70 ml/min.
• FEV1 greater than 1.0 and diffusion capacity greater than 40%
• Age 18-75 years
• Patients must be at high risk for conventional regimen related toxicity
• Malignant hematologic disease that would otherwise be considered treatable with ASCT

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Hematologic Diseases

Interventions

Busulfan; fludarabine; Alemtuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: George Selby, MD
• Organization: University of Oklahoma Health Sciences Center

george-selby@ouhsc.edu

405/271-4022

Study Officials

• George Selby, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: February 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: April 22, 2011
• Results First Posted: April 22, 2011

Record last verified: 2011-03

Locations

US (1)